Zhou Yuheng, Zhao Zerui, Zhai Wenyu, Feng Shoucheng, Sun Weizhen, Lin Yaobin, Long Hao
Department of Thoracic Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.
Lung Cancer Research Center, Sun Yat-sen University, Guangzhou, China.
J Thorac Dis. 2025 May 30;17(5):2947-2957. doi: 10.21037/jtd-2024-2266. Epub 2025 May 28.
The previously reported primary analyses of NeoTAP01 trial demonstrated encouraging effectiveness and safety of perioperative toripalimab plus chemotherapy in resectable stage III non-small cell lung cancer (NSCLC). We now present the 4-year follow-up outcomes in order to confirm the stability of its benefits.
This trial enrolled 33 NSCLC patients with resectable IIIA and IIIB to receive three cycles of neoadjuvant toripalimab plus chemotherapy before surgery. Adjuvant toripalimab was suggested to conduct for 12 cycles postoperatively. With a median follow-up of 4.3 years, long-term outcomes, including event-free survival (EFS), overall survival (OS), and treatment-related adverse effects (TRAEs) were reported. Post hoc analyses explored the risk factors of recurrence in the level of pathologic and genomic characteristics.
In the per-protocol (PP) population, 4-year EFS and OS rates were 66.7% and 83.3%, respectively. The presence of pathologic complete response (pCR) trended toward favorable EFS [4-year EFS, 92.9% 46.7%; hazard ratio (HR), 0.09; 95% confidence interval (CI): 0.01 to 0.76]. All the patients with recurrence in the non-pCR subgroup had received adjuvant treatment, and 75% of them experienced recurrence in less than 1 year after surgery. For the TRAEs, grade 3 pneumonitis happened in 11.1% (3/27) patients during the adjuvant therapy. and mutations were not associated with long-term survival risks.
The 4-year clinical outcomes for perioperative toripalimab plus chemotherapy in resectable stage III NSCLC showed a sustained improvement in long-term EFS and OS. However, the effectiveness of adjuvant immunotherapy are still unclear, as definitive conclusions are limited by cohort size.
先前报道的NeoTAP01试验的初步分析显示，围手术期托瑞帕利单抗联合化疗在可切除的III期非小细胞肺癌（NSCLC）中具有令人鼓舞的有效性和安全性。我们现在展示4年随访结果，以确认其益处的稳定性。
本试验纳入了33例可切除的IIIA期和IIIB期NSCLC患者，在手术前接受三个周期的新辅助托瑞帕利单抗联合化疗。建议术后进行12个周期的辅助托瑞帕利单抗治疗。中位随访4.3年，报告了长期结局，包括无事件生存期（EFS）、总生存期（OS）和治疗相关不良反应（TRAEs）。事后分析在病理和基因组特征水平上探索了复发的危险因素。
在意向性分析（PP）人群中，4年EFS率和OS率分别为66.7%和83.3%。病理完全缓解（pCR）的存在倾向于有良好的EFS[4年EFS，92.9%对46.7%；风险比（HR），0.09；95%置信区间（CI）：0.01至0.76]。非pCR亚组中所有复发患者均接受了辅助治疗，其中75%在术后不到1年出现复发。对于TRAEs，11.1%（3/27）的患者在辅助治疗期间发生3级肺炎。 突变与长期生存风险无关。
围手术期托瑞帕利单抗联合化疗治疗可切除的III期NSCLC的4年临床结局显示，长期EFS和OS持续改善。然而，辅助免疫治疗的有效性仍不明确，因为确切结论受队列规模限制。
